Dexmedetomidine B. Braun
Dexmedetomidine – Alpha-2 adrenergic agonist for ICU and procedural sedation
Quick Facts: Dexmedetomidine B. Braun
Key Takeaways About Dexmedetomidine B. Braun
- Unique sedation profile: Dexmedetomidine produces sedation resembling natural sleep with preserved arousability and minimal respiratory depression, distinguishing it from other ICU sedatives.
- Hospital-only administration: This medication must be given exclusively as an intravenous infusion by experienced healthcare professionals in an ICU or operating room with continuous cardiovascular monitoring.
- Cardiovascular effects require monitoring: Bradycardia (slow heart rate) and hypotension (low blood pressure) are very common side effects, making continuous heart rate and blood pressure monitoring essential.
- Never given as a bolus: Dexmedetomidine B. Braun must only be administered as a continuous infusion via an infusion pump or syringe pump — bolus injections are contraindicated.
- Significant drug interactions: Concurrent use with other sedatives, opioids or anaesthetics may potentiate effects, while concomitant cardiovascular medications may amplify blood pressure and heart rate changes.
What Is Dexmedetomidine B. Braun and What Is It Used For?
Quick Answer: Dexmedetomidine B. Braun is a sedative medication containing the active substance dexmedetomidine, an alpha-2 adrenergic agonist. It is used to provide sedation for adults in intensive care settings and conscious sedation during diagnostic or surgical procedures in hospital environments.
Dexmedetomidine B. Braun contains dexmedetomidine hydrochloride, a highly selective alpha-2 adrenoceptor agonist that belongs to the pharmacological class of sedative agents. Unlike conventional sedatives such as benzodiazepines or propofol, dexmedetomidine acts on specific receptors in the brain's locus coeruleus — the primary noradrenergic nucleus involved in the natural sleep-wake cycle. This mechanism produces a unique form of sedation that closely resembles physiological non-REM sleep, from which patients can be gently aroused for clinical assessments and communication.
The medication is approved for two primary clinical indications. The first is sedation of adult patients in intensive care units (ICUs) who require a sedation level no deeper than arousal in response to verbal stimulation, corresponding to a Richmond Agitation-Sedation Scale (RASS) score of 0 to -3. The second indication is procedural sedation, also known as conscious or awake sedation, of non-intubated adult patients prior to and during diagnostic or surgical procedures that require sedation.
In clinical practice, dexmedetomidine has become increasingly valued in critical care medicine for several important properties. It provides anxiolysis (anxiety reduction) and analgesia (pain relief) alongside sedation, which may reduce the need for concurrent opioid use. Studies published in the New England Journal of Medicine and JAMA have demonstrated that dexmedetomidine-based sedation may be associated with reduced duration of mechanical ventilation, shorter time to extubation, and a lower incidence of delirium compared to traditional sedation regimens.
Dexmedetomidine B. Braun is manufactured by B. Braun Melsungen AG and is supplied as a ready-to-use solution for infusion. The product is available in two concentrations: 4 micrograms/mL (in 50 mL and 100 mL bottles) and 100 micrograms/mL concentrate. Other brand names containing the same active substance include Dexdor, Dexmedetomidine Kalceks, Dexmedetomidine EVER Pharma, and Precedex.
What Should You Know Before Receiving Dexmedetomidine B. Braun?
Quick Answer: Dexmedetomidine B. Braun must not be used if you have an allergy to dexmedetomidine, advanced heart block (grade II or III), unresponsive severe low blood pressure, or have recently had a stroke or serious condition affecting blood flow to the brain. Special caution is needed for patients with low heart rate, low blood pressure, heart problems, liver disease, or advanced age.
Contraindications
You must not receive Dexmedetomidine B. Braun if any of the following apply to you:
- Allergy to dexmedetomidine or any of the other ingredients in this medicine (sodium chloride, water for injections)
- Advanced heart block (second-degree or third-degree atrioventricular block) unless you have a functioning cardiac pacemaker
- Uncontrolled severe hypotension (very low blood pressure that does not respond to treatment)
- Recent acute cerebrovascular event, including stroke or any other serious condition that has recently affected blood flow to the brain
These contraindications are absolute, meaning the drug must not be administered under any of these circumstances. The prescribing physician will thoroughly evaluate your medical history and current condition before initiating dexmedetomidine therapy.
Warnings and Precautions
Before receiving this medication, your doctor or nurse should be informed if any of the following conditions apply, as Dexmedetomidine B. Braun should be used with particular caution:
- Unusually low heart rate (bradycardia): Whether due to underlying cardiac disease or a high level of physical fitness, a pre-existing low heart rate may increase the risk of clinically significant bradycardia or cardiac arrest during dexmedetomidine infusion.
- Low blood pressure (hypotension): Dexmedetomidine commonly causes blood pressure reductions, which may be more pronounced in patients who already have low baseline blood pressure.
- Hypovolaemia (low blood volume): Patients who have experienced recent bleeding, dehydration, or fluid loss are at increased risk of haemodynamic instability with dexmedetomidine.
- Cardiac conditions: Patients with ischaemic heart disease, heart failure, or other cardiovascular disorders require careful monitoring as dexmedetomidine affects both heart rate and blood pressure.
- Advanced age: Elderly patients may be more susceptible to the cardiovascular effects of dexmedetomidine and may require dose adjustments.
- Neurological conditions: Patients with head injury, spinal cord injury, or history of stroke require careful consideration, as alterations in blood pressure and heart rate may affect cerebral perfusion.
- Severe hepatic impairment: Dexmedetomidine is extensively metabolised by the liver. Patients with severe liver disease may experience prolonged or exaggerated drug effects due to reduced clearance.
- History of malignant hyperthermia: If you have ever developed severe high fever after receiving any medication, particularly during anaesthesia, inform your doctor as there is a theoretical risk.
This medication may cause large volumes of urine output and excessive thirst. These symptoms may indicate diabetes insipidus, a hormonal disorder. Contact your doctor immediately if you experience these effects. An increased risk of mortality has been observed in certain ICU patient populations, particularly in non-surgical patients with more severe illness at admission. Your doctor will carefully weigh the benefits and risks of dexmedetomidine sedation compared to alternative sedative agents.
Pregnancy and Breastfeeding
Dexmedetomidine B. Braun should not be used during pregnancy or breastfeeding unless the potential benefit to the mother clearly outweighs the potential risk to the foetus or infant. Animal studies have shown reproductive toxicity at high doses, although direct relevance to humans is uncertain. There are limited clinical data from the use of dexmedetomidine in pregnant women.
If you are pregnant, think you may be pregnant, or are planning to become pregnant, your doctor will discuss whether dexmedetomidine is appropriate for your clinical situation. If the drug is used during breastfeeding, interruption of breastfeeding should be considered during treatment and for a period after the last dose, as dexmedetomidine may be excreted in breast milk.
Driving and Operating Machinery
Dexmedetomidine B. Braun has a major impact on the ability to drive vehicles and operate machinery. After receiving this medication, you must not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Ask your doctor when it is safe to resume these activities. The sedative effects may persist for some time after the infusion is stopped, and individual recovery times vary.
This medicine contains sodium chloride. Each 50 mL bottle contains approximately 177.1 mg sodium (8.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult). Each 100 mL bottle contains approximately 354.2 mg sodium (17.7% of the maximum daily intake). This should be taken into account for patients on a controlled sodium diet.
How Does Dexmedetomidine B. Braun Interact with Other Drugs?
Quick Answer: Dexmedetomidine interacts significantly with other sedatives (midazolam, propofol), opioid analgesics (morphine, fentanyl), anaesthetic agents (sevoflurane, isoflurane), and cardiovascular medications (beta-blockers, calcium channel blockers). These interactions can enhance sedation, respiratory depression, or cardiovascular effects.
Drug interactions with dexmedetomidine are clinically significant and require careful consideration by the treating physician. The alpha-2 adrenergic mechanism of action means that dexmedetomidine can potentiate the effects of many commonly used medications in the ICU and operating room environment. Understanding these interactions is essential for safe and effective use.
Major Interactions
The following medication classes can significantly increase the effects of dexmedetomidine and require dose adjustments or enhanced monitoring:
| Drug/Class | Type of Interaction | Clinical Effect | Recommendation |
|---|---|---|---|
| Midazolam, Diazepam (Benzodiazepines) | Synergistic sedation | Enhanced sedation, increased risk of respiratory depression | Reduce dose of one or both agents; monitor sedation depth |
| Propofol | Synergistic sedation | Deepened sedation, enhanced hypotension | Dose reduction of propofol may be required |
| Morphine, Fentanyl, Codeine (Opioids) | Additive CNS depression | Enhanced sedation, analgesia; potential respiratory depression | Monitor respiratory function; consider opioid dose reduction |
| Sevoflurane, Isoflurane (Volatile anaesthetics) | Reduced anaesthetic requirements | Reduced MAC value; enhanced cardiovascular depression | Reduce anaesthetic concentration; monitor haemodynamics |
| Beta-blockers (Atenolol, Metoprolol) | Additive cardiovascular effects | Enhanced bradycardia and hypotension | Close cardiovascular monitoring; consider dose adjustment |
| Calcium channel blockers (Diltiazem, Verapamil) | Additive cardiovascular effects | Enhanced bradycardia and blood pressure reduction | Monitor heart rate and blood pressure closely |
Minor Interactions and Precautions
Dexmedetomidine should not be used concurrently with neuromuscular blocking agents (muscle relaxants), as there is no established compatibility data and the combination may lead to unpredictable effects. Patients receiving antihypertensive medications of any class should be aware that dexmedetomidine may potentiate blood pressure-lowering effects.
Although dexmedetomidine is primarily metabolised by hepatic enzymes (CYP2A6, glucuronidation, and N-methylation), clinically significant pharmacokinetic interactions via cytochrome P450 inhibition or induction are not well established. However, drugs that significantly alter hepatic blood flow or function may theoretically affect dexmedetomidine clearance.
It is essential to inform your healthcare team about all medications you are currently taking, have recently taken, or may be prescribed during your hospital stay. This includes prescription medications, over-the-counter drugs, and herbal supplements.
What Is the Correct Dosage of Dexmedetomidine B. Braun?
Quick Answer: Dexmedetomidine B. Braun is administered as a continuous intravenous infusion. For ICU sedation, infusion rates typically range from 0.2 to 1.4 micrograms/kg/hour. For procedural sedation, a loading dose of 1 microgram/kg over 10 minutes is usually given, followed by a maintenance infusion of 0.2 to 1 microgram/kg/hour. Doses are individualised based on patient response.
Dexmedetomidine B. Braun is a ready-to-use solution that must not be diluted before use. It is administered exclusively as an intravenous infusion using an infusion pump or syringe pump. It must never be given as a bolus injection. The dosage is individualised based on the patient's age, body weight, general health status, desired level of sedation, and clinical response. Continuous monitoring of heart rate, blood pressure, and oxygen saturation is mandatory throughout the infusion.
Adults — ICU Sedation
ICU Sedation (Intubated or Non-Intubated Patients)
Loading dose: A loading infusion of 0.5 to 1.0 microgram/kg over 20 minutes may be administered, although it is often omitted in haemodynamically unstable patients to reduce the risk of transient hypertension followed by hypotension.
Maintenance infusion: Usually initiated at 0.2 to 0.7 micrograms/kg/hour. The infusion rate is titrated to the desired level of sedation, typically targeting a RASS score of 0 to -3. The maximum recommended rate is 1.4 micrograms/kg/hour.
Duration: Clinical experience with infusions lasting more than 14 days is limited. The infusion should be regularly reassessed and titrated to the minimum effective dose.
Adults — Procedural Sedation
Procedural (Conscious) Sedation
Loading dose: 1.0 microgram/kg administered over 10 minutes. For less invasive procedures or more fragile patients, a loading dose of 0.5 microgram/kg over 10 minutes may be sufficient.
Maintenance infusion: Usually initiated at 0.6 to 0.7 micrograms/kg/hour and titrated to achieve the desired clinical effect. Typical maintenance rates range from 0.2 to 1.0 microgram/kg/hour. The rate should be adjusted based on the level of sedation required for the specific procedure.
Elderly Patients
No specific dose adjustment is mandated for elderly patients. However, elderly patients may be more susceptible to the pharmacological effects of dexmedetomidine, particularly cardiovascular effects such as bradycardia and hypotension. The prescribing physician should consider initiating treatment at the lower end of the dosing range, titrating carefully, and monitoring closely. Reduced doses may be appropriate based on individual clinical response and tolerance.
Hepatic and Renal Impairment
Dexmedetomidine is extensively metabolised in the liver. In patients with severe hepatic impairment, the clearance of dexmedetomidine is significantly reduced, which may result in prolonged and enhanced pharmacological effects. Dose reduction should be considered, and these patients require particularly careful monitoring. No dose adjustment is required for patients with renal impairment, as only a small fraction of unchanged dexmedetomidine is excreted in the urine.
Children and Adolescents
The safety and efficacy of Dexmedetomidine B. Braun in children and adolescents below 18 years of age have not been established. There are currently insufficient data to support a recommendation for use in paediatric patients. Use in this population should only be considered in exceptional circumstances under specialist supervision.
Overdose
In the event of an overdose with dexmedetomidine, the anticipated clinical effects include exaggerated pharmacological responses: pronounced sedation, significant bradycardia, hypotension, and potentially cardiac arrest in severe cases. Initial hypertension may also occur before hypotension develops. Treatment is supportive and symptom-directed. The infusion should be immediately discontinued. Bradycardia may respond to atropine or glycopyrrolate. Hypotension may require intravenous fluid resuscitation and, if necessary, vasopressor support. In severe overdose, resuscitation measures should follow standard advanced life support protocols. There is no specific antidote for dexmedetomidine.
What Are the Side Effects of Dexmedetomidine B. Braun?
Quick Answer: The most common side effects of dexmedetomidine are cardiovascular in nature: bradycardia (slow heart rate), hypotension (low blood pressure), hypertension (high blood pressure), and respiratory changes. Common side effects include nausea, dry mouth, and agitation. Most side effects occur during the infusion and are manageable with dose adjustment.
Like all medicines, dexmedetomidine can cause side effects, although not everyone will experience them. Most side effects are related to its pharmacological mechanism of action on the cardiovascular system and are dose-dependent. They typically resolve with dose reduction or discontinuation of the infusion. The following side effects have been reported in clinical trials and post-marketing surveillance:
Very Common
May affect more than 1 in 10 patients
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Hypertension (high blood pressure)
- Respiratory depression or changes in breathing pattern
Common
May affect up to 1 in 10 patients
- Chest pain or myocardial ischaemia (heart attack)
- Tachycardia (fast heart rate)
- Hyperglycaemia (high blood sugar)
- Hypoglycaemia (low blood sugar)
- Nausea and vomiting
- Dry mouth (xerostomia)
- Agitation and restlessness
- Pyrexia (fever)
- Withdrawal symptoms upon discontinuation
Uncommon
May affect up to 1 in 100 patients
- Reduced cardiac output or cardiac arrest
- Abdominal distension
- Thirst
- Metabolic acidosis
- Hypoalbuminaemia (low albumin levels)
- Dyspnoea (shortness of breath)
- Hallucinations
- Inadequate effectiveness of sedation
Frequency Not Known
Reported in post-marketing surveillance
- Polyuria with excessive thirst — may indicate diabetes insipidus, a hormonal disorder; contact your doctor immediately if this occurs
Contact your healthcare team immediately if you experience severe bradycardia, sudden chest pain, difficulty breathing, persistent very low blood pressure, or excessive urine production with unquenchable thirst. These symptoms may require urgent medical intervention including dose adjustment or discontinuation of the infusion.
The cardiovascular side effects (bradycardia and hypotension) are a direct consequence of the alpha-2 adrenergic agonist mechanism and are generally predictable. Transient hypertension may occur at the start of the infusion, particularly with a loading dose, due to peripheral alpha-2 receptor activation causing vasoconstriction before central effects predominate. This initial hypertensive response is typically self-limiting.
Withdrawal effects have been reported following prolonged infusions, particularly in ICU settings. Symptoms may include agitation, tachycardia, and hypertension. Gradual dose tapering rather than abrupt discontinuation may help mitigate withdrawal phenomena, especially after prolonged use exceeding 24 hours.
If you experience any side effects, including those not listed above, inform your doctor, nurse, or pharmacist. Reporting suspected adverse reactions contributes to the ongoing monitoring of the benefit-risk balance of medicines.
How Should Dexmedetomidine B. Braun Be Stored?
Quick Answer: Dexmedetomidine B. Braun requires no special storage conditions. It should be kept out of the sight and reach of children, used immediately after opening, and must not be used after the expiry date or if the solution is not clear, colourless, and free of particles.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date refers to the last day of that month.
There are no special storage requirements for unopened vials of Dexmedetomidine B. Braun. The product does not need refrigeration and can be stored at room temperature. However, once opened, the solution should be used immediately. Any unused portion should be discarded in accordance with local pharmaceutical waste disposal regulations.
Before use, visually inspect the solution. Do not use this medicine if the solution is not clear, colourless, and free from visible particles. Discoloured or turbid solutions, or solutions containing particulate matter, must not be administered. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
What Does Dexmedetomidine B. Braun Contain?
Quick Answer: The active ingredient is dexmedetomidine (as hydrochloride). The 4 microgram/mL solution contains 200 micrograms per 50 mL bottle or 400 micrograms per 100 mL bottle. The other ingredients are sodium chloride and water for injections.
Active Ingredient
The active substance is dexmedetomidine, present as dexmedetomidine hydrochloride. Dexmedetomidine B. Braun is available in two concentrations:
| Formulation | Concentration | Total Content | Bottle Size |
|---|---|---|---|
| 4 microg/mL | 4 micrograms dexmedetomidine per mL | 200 micrograms (50 mL) or 400 micrograms (100 mL) | 50 mL or 100 mL polyethylene bottles |
| 8 microg/mL | 8 micrograms dexmedetomidine per mL | 400 micrograms (50 mL) | 50 mL polyethylene bottle |
Inactive Ingredients (Excipients)
The other ingredients are:
- Sodium chloride: Used as a tonicity agent to make the solution isotonic with blood plasma
- Water for injections: The solvent used to prepare the sterile solution
Appearance and Packaging
Dexmedetomidine B. Braun is a clear, colourless solution for infusion. The bottles are made of polyethylene with two-port closures sealed with latex-free rubber. The product is available in the following pack sizes:
- 4 microg/mL: 10 × 50 mL bottles; 10 × 100 mL bottles
- 8 microg/mL: 10 × 50 mL bottles
Not all pack sizes may be marketed in all countries.
Administration Notes for Healthcare Professionals
Dexmedetomidine B. Braun is a ready-to-use solution that must not be diluted before use and must not be mixed with other medications. It must be administered exclusively as an intravenous infusion using a calibrated infusion pump or syringe pump. Compatibility studies have shown a potential for dexmedetomidine to adsorb to certain types of natural rubber. Although the drug is dosed to clinical effect, it is advisable to use components with synthetic rubber gaskets or coated natural rubber gaskets to minimise potential adsorption losses.
Frequently Asked Questions About Dexmedetomidine B. Braun
Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist. It works by activating alpha-2 receptors in the locus coeruleus of the brain, the region responsible for regulating the sleep-wake cycle. This produces a state of sedation that closely resembles natural non-REM sleep, with the unique advantage of allowing patients to be aroused for neurological assessments. Unlike benzodiazepines and propofol, dexmedetomidine achieves sedation without significant respiratory depression, making it particularly valuable in intensive care and procedural settings.
Dexmedetomidine B. Braun differs from traditional ICU sedatives in several important ways. First, it produces "cooperative sedation" — patients can be sedated yet aroused for clinical assessments, which is difficult to achieve with propofol or midazolam. Second, it has minimal respiratory depressant effects, so patients can often maintain their own airway and breathing. Third, it provides inherent analgesic properties that may reduce the need for concurrent opioid use. Clinical studies have also shown that dexmedetomidine may be associated with a lower incidence of ICU delirium compared to benzodiazepine-based sedation.
The safety and efficacy of Dexmedetomidine B. Braun have not been established in patients under 18 years of age. While there is growing clinical experience with dexmedetomidine in paediatric populations, particularly for procedural sedation and ICU use, its use in children and adolescents remains off-label for this specific product. Paediatric use should only be considered in exceptional circumstances under the supervision of a specialist with experience in paediatric sedation, and with appropriate monitoring equipment available.
Continuous monitoring is mandatory during dexmedetomidine infusion. This includes continuous electrocardiography (ECG) to detect bradycardia or arrhythmias, continuous pulse oximetry for oxygen saturation, frequent blood pressure measurements (typically every 5 to 15 minutes initially, then at appropriate intervals), and regular assessment of sedation depth using validated scales such as the Richmond Agitation-Sedation Scale (RASS). Respiratory rate should be monitored continuously. For ICU patients, additional monitoring may include central venous pressure, cardiac output, and end-tidal CO2 as clinically indicated.
The elimination half-life of dexmedetomidine is approximately 2 hours in healthy adults, but this can be prolonged in patients with hepatic impairment or after prolonged infusions. After stopping the infusion, sedative effects typically begin to wear off within 30 to 60 minutes, although complete recovery may take several hours depending on the duration of the infusion, total dose administered, and individual patient factors. Your healthcare team will continue to monitor you for several hours after the infusion is discontinued to ensure safe recovery before discharge or resumption of normal activities.
Yes, withdrawal symptoms have been reported following discontinuation of dexmedetomidine, particularly after prolonged infusions (more than 24 hours) in ICU patients. Symptoms may include agitation, anxiety, tachycardia, hypertension, and nausea. To minimise the risk of withdrawal, gradual dose tapering rather than abrupt discontinuation is recommended after prolonged use. Your medical team will carefully plan the weaning process to ensure a smooth transition to alternative sedation strategies or to wakefulness.
References
This article is based on the following peer-reviewed sources, regulatory documents, and clinical guidelines:
- European Medicines Agency (EMA). Dexmedetomidine – Summary of Product Characteristics. EMA/HMPC, 2024.
- U.S. Food and Drug Administration (FDA). Precedex (dexmedetomidine hydrochloride) – Prescribing Information. FDA, 2023.
- Jakob SM, Ruokonen E, Grounds RM, et al. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012;307(11):1151-1160.
- Pandharipande PP, Pun BT, Herr DL, et al. Effect of sedation with dexmedetomidine vs lorazepam on acute brain dysfunction in mechanically ventilated patients: the MENDS randomized controlled trial. JAMA. 2007;298(22):2644-2653.
- Riker RR, Shehabi Y, Bokesch PM, et al. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009;301(5):489-499.
- British National Formulary (BNF). Dexmedetomidine – Indications, dose, contra-indications, side effects. NICE, 2024.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. WHO, 2023.
- B. Braun Melsungen AG. Dexmedetomidine B. Braun – Package Leaflet: Information for the User. Revised June 2024.
- Weerink MAS, Struys MMRF, Hannivoort LN, et al. Clinical pharmacokinetics and pharmacodynamics of dexmedetomidine. Clinical Pharmacokinetics. 2017;56(8):893-913.
- Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015;75(10):1119-1130.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of specialist physicians with expertise in anaesthesiology, intensive care medicine, and clinical pharmacology.